1,463 recalls · Class I, newest first
Reason Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain…
Reason Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Reason Product Mix-up: Incorrect diluent component included in the kit.
Reason Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Reason Non-Sterility: firm's third party lab confirmed microbial contamination.
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was…
Reason Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Reason Hand sanitizer packaged in bottles that resemble beverage containers.
Reason Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis…
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Reason Non-Sterility
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety…
Reason Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and…
Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and…
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.